Amarillo, Texas, February 16, 2010 — Amarillo Biosciences, Inc. (ABI) (OTCBB: AMAR) today announced additional preliminary results from the recently completed Phase 2 clinical trial conducted in Perth, Australia at the University of Western Australia with Professors David Smith and Manfred Beilharz as principal investigators.
The Company previously reported results of a post-hoc analysis, which found that subjects given interferon who had received seasonal influenza vaccine prior to enrollment had a significantly lower incidence of influenza-like illness during the study, compared to subjects in the placebo group who had been vaccinated. Further exploratory analyses have discovered that the incidence of influenza-like illness, the primary study endpoint, was significantly reduced from 60% to 24% in subjects 55 years of age or older who received interferon, compared to subjects in the placebo group who were at least 55 years old at the start of the study.
Similar to what has been observed in studies of other human diseases, preliminary analysis indicates that low-dose oral interferon therapy was safe in this study. No significant differences were found between the groups in the number or severity of adverse events reported. Placebo subjects reported an average of 1.4 adverse events, compared to an average of 1.3 adverse events reported per interferon-treated subject.
A total of 200 healthy human volunteers were enrolled in this study to take a once daily dose of oral interferon or placebo for 16 weeks as prevention of influenza-like illness during the 2009 Australian cold and flu season. The H1N1 (2009) influenza virus was the major circulating virus in Perth during the duration of the trial and was estimated to account for at least 90% of influenza viruses, according to the Australian Department of Health of Western Australia. Blood samples were collected at the beginning and the end of the study for serological analysis. Once available, these serology data will help identify those subjects who had an increase in antibodies to particular cold and flu viruses, including the H1N1 (2009) influenza virus.
Separately, ABI announced that Oromucosal Administration of Interferon to Humans, a review article authored by Manfred W. Beilharz and others, was published in Pharmaceuticals. The article may be viewed at: http://www.mdpi.com/1424-8247/3/2/323.
About Amarillo Biosciences
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 5.9% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including influenza, hepatitis C, chronic cough, and opportunistic infections in patients who are HIV positive. In its 25-year history, the Company has invested nearly $40 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web site at http://www.amarbio.com/.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company’s other product candidates and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. In particular, see “Item 1. Description of Business” and “Item 7A. Qualitative and Quantitative Disclosures About Market Risk” of the Company’s Form 10-K for the fiscal year ended December 31, 2008. --END--